Kornimate/medical-research-clean huggingface dataset:
molecular signatures associated with response to ics treatment in patients with copd stratified by eosinophil levels

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the 3tr-ics copd study is an international, multicentre, randomized, parallel, controlled study that will recruit clinically stable former smokers copd patients (with no exacerbations in the previous 8 weeks) on treatment with dual long-acting bronchodilators (laba+lama), minimum 8 weeks of usage, not receiving ics (either naïve or \> 3 months since last usage). the overall objective of this clinical trial is to identify the molecular signatures associated with the molecular response to ics treatment in patients with copd stratified by the levels of circulating eosinophils, and the potential influence of the pulmonary microbiome


Eligibility criteria:
inclusion criteria: * male and female patients ≥40 years of age. * ≥ 10 pack-years smoking. * former smokers (≥6 months). * post-bronchodilator fev1/fvc\<0.70. * fev1 ≥30 \<80% ref. * signed written informed consent form. * on regular treatment with dual long-acting bronchodilators (laba+lama), minimum 8 weeks of usage. * women of child-bearing potential\* must have a negative pregnancy test in serum or urine before the inclusion in the study and agree to use highly effective contraceptive methods during the study. highly effective contraceptive methods will include: intrauterine device, bilateral tubal occlusion, vasectomized partner and sexual abstinence. * hormonal contraceptive methods will be avoided due to the risk of adverse events and impairment of liver function. exclusion criteria: * presence of other respiratory disorders, (i.e. current physician diagnosis of asthma, early life history of asthma (\<21 years) a previous clinical diagnosis of bronchiectasis, interstitial lung disease, pulmonary eosinophilia). * long-term oxygen therapy or non-invasive mechanical ventilation at home. * current smokers. * active cancer. * use of ics in the 3 months prior to the recruitment. * participating in another randomized trial. * not likely to complete the study. * pregnant or breastfeeding females. * exacerbations in the previous 8 weeks. * primary or secondary immunodeficiency. * immunosuppression or regular oral corticosteroid treatment. * allergy to imp's excipients. * any circumstances which could contradict study participation and lead the investigator to assess the patient as unsuitable for study participation for any other reason.
endothelial dysfunction and chronic obstructive pulmonary disease

Conditions: Chronic Obstructive Pulmonary Disease; Endothelial Dysfunction

Summary: the purpose of this study is to investigate the role of endothelial dysfunction in chronic obstructive pulmonary disease.

chronic obstructive pulmonary disease (copd) is one of the leading causes of death in developed countries. acute exacerbations and cardiovascular diseases are the major causes of morbidity and mortality in copd patients. according to the frequency of exacerbations, phenotype "frequent exacerbator" is defined and characterised with severe clinical course and was recognised as an increased risk for cardiovascular mortality. recent studies considered that systemic inflammation plays a key role in the pathogenesis of copd and endothelial dysfunction is a suspected link between increased cardiovascular mortality and systemic inflammation in copd patients. endothelial dysfunction is assessed by determining flow mediated dilatation index (fmd index) or plasma markers. previous studies have suggested the presence of endothelial dysfunction in copd patients, as well as the deterioration of endothelial function during exacerbations of copd. this study will, for the first time, systematically explore endothelial dysfunction in two phenotypically distinct groups of copd patients with simultaneous assessment of endothelial function flow mediated dilatation index (fmd index) and plasma markers.

Eligibility criteria:
inclusion criteria: * copd patients in stable condition ( without exacerbation min 1 months ago) * over 40 years * history of at least 10 py exclusion criteria: * acute exacerbation of copd * active malignancy * autoimmune disease * acute myocardial infarction * diabetes mellitus with late complications * congestive heart failure * women of childbearing potential

Keywords: chronic obstructive pulmonary disease frequent exacerbator endothelial dysfunction flow mediated dilatation systemic inflammation
the endoscopic assesment of intestinal grafts

Conditions: Transplant; Intestine; Transplant; Complication, Rejection; Transplant; Failure, Bowel; Enteritis; Mucosal Inflammation

Summary: the study validates prospectively a new endoscopic scoring system (gothenburg intestinal transplant endoscopy score, gites) designed to summarize and stratify the abnormal ileal endoscopic findings after intestinal transplantation. gites is a five-tier, four grade score which asseses mucosal friability, mucosal erythema and mucosal injury (ulcerations) as well as villous changes according to severity. these features (i.e., endoscopic descriptors) are also grouped from mild to very severe in the same sequence as observed during the progression of several pathologic conditions encountered after intestinal transplantation (acute rejection, infectious enteritis).


Eligibility criteria:
inclusion criteria: * transplantation of a segment of small intestine (as isolated graft or together with other organs) exclusion criteria: * contraindications for ileoscopy

Keywords: transplantation; intestine endoscopy severity score transplant rejection transplant; complications
clinical investigation of a toothpaste containing stannous fluoride as compared to colgate fluoride toothpaste

Conditions: Gingivitis

Summary: the objective of this study is to evaluate the clinical efficacy of a toothpaste containing stannous fluoride as compared to colgate fluoride toothpaste in reducing plaque and gingivitis - a three- month study.

this was a 6-month, randomized, single-center, parallel group, double-blinded, clinical research study to assess the clinical efficacy of two toothpastes containing stannous fluoride (snhw and cph) as compared to regular fluoride toothpaste on the reduction of established dental plaque and gingivitis in adults.

Eligibility criteria:
inclusion criteria: * subjects, ages 18-70, inclusive. * availability for the six-month duration ofthe clinical research study. * good general health. * minimum of 20 uncrowned permanent natural teeth (excluding third molars). * initial gingivitis index of at least 1.0 as determined by the use of the loe and silness gingival index. * initial plaque index of at least 1.5 as determined by the use of the quigley and hein °plaque index (turesky modification). * signed informed consent form. exclusion criteria: * presence of partial denture. * presence of partial removable dentures. * tumor(s) of the soft or hard tissues of the oral cavity. * advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone). * five or more carious lesions requiring immediate restorative treatment. * antibiotic use any time during the one month prior to entry into the study. * participation in any other clinical study or test panel within the one month prior to entry into the study. * dental prophylaxis during the past two weeks prior to baseline examinations. * history of allergies to oral care/personal care consumer products or their ingredients. * on any prescription medicines that might interfere with the study outcome. * an existing medical condition which prohibits eating or drinking for periods up to 4 hours. * history of alcohol or drug abuse. * pregnant or lactating subjects.
assessment of traumatic brain injury using transcranial magnetic stimulated evoked potentials

Conditions: Traumatic Brain Injury

Summary: patients evaluated at penn presbyterian medical center for traumatic brain injury (tbi), who sign the informed consent, will undergo assessment of electrophysiologic potentials evoked by transcranial magnetic stimulation (tms), using the delphi-md device (quantalx neuroscience ltd., saba israel).


Eligibility criteria:
inclusion criteria for traumatic brain injury (acute, subacute, chronic) group: 1. age 18 years and older 2. evidence of mechanical energy impacting the head or inertial forces affecting the head 3. either (a) or (b): 1. trauma-related abnormality on ct scan on admission 2. if ct normal, documented/verified tbi based on evidence of either loss of consciousness, post-traumatic amnesia, confusion, or post-traumatic symptoms. exclusion criteria for traumatic brain injury (acute, subacute, chronic) group: 1. history of disabling pre-existing neurologic disease (such as epilepsy, brain tumors, meningitis, cerebral palsy, encephalitis, brain abscesses, vascular malformations, cerebrovascular disease, alzheimer's disease, multiple sclerosis, or hiv-encephalitis) 2. history of premorbid disabling condition that interfere with outcome assessments 3. bilaterally absent pupillary responses 4. penetrating traumatic brain injury 5. prisoners or patients in police custody 6. pregnancy 7. subjects with magnetic-sensitive devices implanted in their head or within 12 in. (30 cm) of the coil/probe (examples: cochlear implants, deep brain stimulators, vagus nerve stimulators, other implanted electrodes/stimulators, aneurysm clips or coils, stents and bullet fragments). inclusion criteria for healthy control group: 1. age 18 years and older 2. no history of tbi in the past 12 months exclusion criteria for healthy control group: 1. history of disabling pre-existing neurologic disease (such as epilepsy, brain tumors, meningitis, cerebral palsy, encephalitis, brain abscesses, vascular malformations, cerebrovascular disease, alzheimer's disease, multiple sclerosis, or hiv-encephalitis) 2. history of premorbid disabling condition that interfere with outcome assessments 3. prisoners or patients in police custody 4. pregnancy 5. subjects with magnetic-sensitive devices implanted in their head or within 12 in. (30 cm) of the coil/probe (examples: cochlear implants, deep brain stimulators, vagus nerve stimulators, other implanted electrodes/stimulators, aneurysm clips or coils, stents and bullet fragments).

Keywords: tbi traumatic brain injury tms-eeg neurological disorders
social media markers of adolescents' suicide hazard

Conditions: Adolescent Suicidality

Summary: suicide is the 2nd leading cause of death for teenage youth in canada, and every year tens of thousands of young people engage in suicidal behaviors. many young people manifest red-flag behaviors in the digital realm before these incidents occur. the faceless nature of online communication often emboldens youth to reveal details about their mental state: leaving tell-tale signs or "bread crumbs" of their suicidal intentions or behaviors. this research will examine the content of adolescents social media entries to find red flags and detect patterns in social media interactions of adolescents that could be predictive of subsequent suicide risk. the study participants will be patients admitted to child and adolescent psychiatry emergency unit at bcch, subdivided into two groups: those admitted due to suicidal behaviors, and those admitted for non-suicidal behaviors. the text of social media activity for the month prior to emergency admission of the two groups will be collected, anonymized, and analyzed using text-analytic algorithms. the objective of the study is to find patterns and indicators of social media entries, prior to admission, that would have been predictive of suicidality. the implications of successful outcome of this project for mental health care of children and adolescents reaches well beyond the scope of this study. an objective method to predict risk of suicidal behaviors in youth has application in almost all pediatric clinical settings. the outcomes of this project will also serve as the foundation for further utilization of social sensing technology to identify, predict, and prevent many other mental health crises in children and adolescents.


Eligibility criteria:
inclusion criteria: * use social media * patient of bcch exclusion criteria: * no use of social media
a trial of levodopa in angelman syndrome

Conditions: Angelman Syndrome

Summary: this study is designed to determine whether levodopa will lead to an improvement in the development and tremor in children with angelman syndrome (as). it has been suggested that levodopa, a medication that is usually used to treat parkinson disease in adults, may help children with as in their overall development and reduce the tremor that some of them have. if levodopa is found to be beneficial for children with as, this could lead to a new treatment for as. funding source - fda-oopd

levodopa is a prodrug that "delivers" dopamine to the brain. it is usually given with carbidopa, a peripheral decarboxylase inhibitor, to increase the bioavailability of levodopa. animal studies have suggested that levodopa can reverse the excess phosphorylation of some enzymes involved in synaptic and neuronal function, including calcium/calmodulin-dependent kinase type 2 (camkii). recently, it was shown that excess phosphorylation of camkii may be responsible for some of the neurological deficits seen in angelman syndrome. therefore, it is hypothesized that levodopa may lead to an improvement in the neurodevelopment and abnormal movements (e.g. tremors) in children with angelman syndrome. although many children have used levodopa for a variety of medical conditions over the last 30 years, it has not been approved by the food and drug administration (fda) for use in children, and it has not been formally studied in children with angelman syndrome. therefore, the purpose of this study is to find out whether levodopa will lead to an improvement in the development and in the tremor in children with as.

Eligibility criteria:
inclusion criteria: 1. age between 4 years and 12 years (i.e., before the 13th birthday) 2. molecular confirmation of the diagnosis of as, which may include abnormal methylation studies or ube3a mutation analyses - only subjects with a molecular diagnosis will be allowed to enroll 3. not on ld, cd, or any dopamine agonists in the 2 weeks prior to participation exclusion criteria: 1. co-morbid disorders that may be associated with developmental or cognitive delays 2. poorly controlled seizures - an average of more than 2 clinical seizures per month in the 12 months prior to enrollment. 3. use of medications that may interact with ld/cd including atypical antipsychotics (aripiprazole, asenapine, iloperidone, olanzapine, paliperidone, risperidone, ziprasidone), monoamine oxidase inhibitors (isocarboxazid, phenelzine, selegiline, tranylcypromine), or phenytoin within the last 14 days, or other investigational interventions within the past 3 months 4. presence of cardiovascular disease or instability, respiratory disease, liver disease, peptic ulcer disease, renal impairment, or hematological disorders 5. pregnancy

Keywords: angelman syndrome levodopa carbidopa l-dopa
adult sexual risk behavior among women with a history of childhood sexual abuse

Conditions: HIV Infections; Child Abuse, Sexual

Summary: this study will evaluate whether childhood experiences are related to current sexual behavior of adult women.

adverse childhood events, including physical and sexual abuse, can cause significant distress for those affected, during both childhood and adulthood. childhood abuse appears to increase the risk of a number of negative outcomes later in life, including psychiatric disorders, substance abuse, and hiv and sexually transmitted infections. previous research has consistently found an association between childhood sexual abuse and greater rates of adult sexual risk behavior. however, improved understanding of how childhood sexual abuse relates to adult sexual risk behavior is needed. the information-motivation-behavioral skills and traumagenic dynamics models are theories used to investigate determinants of sexual behavior and effects of childhood abuse. using these models to examine the relationship between childhood sexual abuse and adult sexual risk behavior may help in creating effective sexual risk reduction interventions for women abused during childhood. this study will evaluate whether childhood experiences are related to current sexual behavior of adult women. the study will also evaluate which theory, the information-motivation-behavioral skills model or the traumagenic dynamics model, better mediates the relationship between childhood sexual abuse and adult sexual risk behavior. participation in this study will include one study visit. participants will first complete a 45-minute computerized survey that includes questions about childhood experiences; family environment; current health and behavior; attitudes, knowledge, and thoughts about sex and relationships; control over life circumstances; and substance use. participants will then engage in two brief role plays in which they will either make a request of their partner or must stand up for themselves. for the last part of the visit, participants will be asked questions about condoms and condom use and will be asked to place a condom on a model used in the clinic.

Eligibility criteria:
inclusion criteria: * understands english exclusion criteria: * impaired mentally

Keywords: sexual behavior hiv sexually transmitted diseases
clinical trial to evaluate the efficacy and safety of naftopidil in male patients with lower urinary tract symptoms associated with benign prostatic hyperplasia

Conditions: Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia

Summary: this study is designed to evaluate the efficacy and safety of naftopidil in korean male patients with with lower urinary tract symptoms associated with benign prostatic hyperplasia. the investigators hypothesized that naftopidil which came onto marcket in japan would effect in improvement of voiding and storage difficulty. design: placebo-controlled, randomized, double-blind, double-dummy, parallel group, fixed dose design


Eligibility criteria:
inclusion criteria: * male patients aged 4 years or more diagnosed with bph exclusion criteria: * subjects with uncontrolled blood pressure * subjects with hepatic or renal dysfunction * subjects with prostate cancer * had treatments for bph using other alpha receptor antagonists within 2 weeks
vandetanib gemcitabine or placebo plus gemcitabine or vandetanib monotherapy in advanced biliary tract cancer

Conditions: Biliary Tract Cancer; Gallbladder Cancer; Cancer Of The Extrahepatic Bile Duct; Ampullary Carcinoma

Summary: the primary objective of the trial is to determine the efficacy of vandetanib monotherapy or vandetanib plus gemcitabine or placebo plus gemcitabine in prolonging the progression-free survival (pfs) at the trial closure in patients with advanced (unresectable or metastatic) biliary tract cancer.


Eligibility criteria:
inclusion criteria: * histologically or cytologically-confirmed advanced (unresectable or metastatic) biliary tract cancer (gallbladder cancer, cancer of the extrahepatic bile duct, intrahepatic cholangiocarcinoma and ampullary carcinoma) * patients must have measurable or evaluable but non-measurable disease * chemotherapy-naïve (prior chemotherapy in the adjuvant setting completed more than 3 months before the trial entry is accepted). * who performance status 0 to 2: patients must have a who ps ≤ 2 exclusion criteria: * patients must not have received prior systemic therapy for advanced (unresectable or metastatic) disease; prior chemotherapy in the adjuvant setting within 3 months before the trial entry is accepted * inadequate end-organ function or evidence of severe or uncontrolled systemic disease or any concurrent condition which in the investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardize compliance wit * significant cardiovascular event (e.g. myocardial infarction, superior vena cava \[svc\] syndrome, new york heart association \[nyha\] classification of heart disease ³2) within 3 months before entry, or presence of cardiac disease that in the opinion of * history of arrhythmia or qtc with bazett's correction unmeasurable or ≥ 480 msec on screening ecg

Keywords: intrahepatic cholangiocarcinoma vandetanib zactima advanced biliary tract gallbladder extrahepatic bile duct intrahepatic cholangiocarcinoma ampullary carcinoma
non-fatal outcome after trauma

Conditions: Trauma

Summary: the major aim of this project is to investigate the prevalence, recovery patterns and risk factors for health related quality of life functional, psychological, societal and economic outcome after trauma. another aim is to validate the who quality of life-bref (whoqol-bref) questionnaire for the trauma population.

patients aged 18 years and older admitted in a hospital in brabant after a trauma, independent of severity or type of injury are included in the study. patients who decease during hospital stay or transferred to another hospital outside the borders of trauma region brabant will be excluded. socio-demographic characteristics, functional and psychological outcome and health related quality of life (hrqol) shortly after trauma will be measured. subsequently the same items will be measured after 1, 3, 6, 12 and 24 months. outcomes will be assessed using questionnaires. the primary outcome parameters are: short and long term hrqol, functional and psychological outcome, and healthcare and societal costs in injured patients. secondary outcome measures are return to work and health care consumption.

Eligibility criteria:
inclusion criteria: * patients seen at the ed which are admitted to the icu or ward after getting injured * all types and severities of injury (injury severity score (iss) 1-75) * a minimal age of 18 years old * sufficient knowledge of the dutch language exclusion criteria: * patients who are dead on arrival or decease in the ed * pathological fracture (i.e., the bones are weakened by disease, for example by a tumor) * patients who die in the hospital will drop out the study and will not be included in the analyses

Keywords: injury risk factors outcome costs
characterization of the autofluorescence of healthy and pathological tissues of vocal cords

Conditions: Laryngeal Neoplasms

Summary: the aim of this clinical trial is to provide information about autofluorescence of pathological versus healthy vocal folds tissues. experimentations are performed on vocal folds biopsies obtained from patients, surgered at ent department, university hospital of besançon. after being extracted, samples of vocal folds are submitted to excitations at 365 nm, 405 nm and 450 nm; light spectral absorptions are measured, and results are compared to reference anatomopathology.


Eligibility criteria:
inclusion criteria: * patient view in ent department, presenting vocal fold lesion that necessitate biopsy * patient informed and with non opposition exclusion criteria: * small (\<1mm) and/or brittle sample * patients in emergency situations, pregnant or nursing mothers, persons deprived of their liberty, minors or protected adults.
cocaine abuse and adhd - 10

Conditions: Cocaine-Related Disorders

Summary: the purpose of this study is to evaluate the safety and efficacy of buproprion in treating individuals with adult attention-deficit hyperactivity disorder (adhd) and cocaine dependence.


Eligibility criteria:
please contact site for information.

Keywords: cocaine dependence